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Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study

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ClinicalTrials.gov Identifier: NCT00342992
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

June 19, 2006
June 21, 2006
September 27, 2018
August 31, 1985
Not Provided
Cancer [ Time Frame: Annually ]
Annual linkage with Finnish Cancer Registry
Not Provided
Complete list of historical versions of study NCT00342992 on ClinicalTrials.gov Archive Site
Causes of mortality [ Time Frame: Anually ]
Not Provided
Not Provided
Not Provided
 
Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study
Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC Study) Population

The project is a passive follow-up of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study cohort. Originally, this was a large, randomized, double-blind, placebo-controlled, 2x2 factorial primary prevention trial testing the effects of alpha-tocopherol and beta-carotene supplementation on cancer incidence and mortality. The study was conducted in Finland as a collaboration between the U.S. National Cancer Institute (NCI) and the National Public Health Institute of Finland. NCI has maintained passive surveillance of the cohort through Finnish national registries, including the cancer registry.

The primary purpose of the ATBC cohort follow-up is to use the existing risk factor data and biological specimens (i.e., serum, whole blood, DNA, red blood cells, and toenails) to test hypotheses relevant to cancer etiology, survival, early detection, and prevention. These data and biospecimens continue to provide an invaluable resource for the study of biochemical, nutritional, genetic, and molecular hypotheses. These analyses are made all the more informative and powerful by the addition of cases identified annually during the follow-up period, and the research benefits from a longer pre-diagnosis period (now over 30 years).

The ATBC study was a randomized, double-blind, placebo-controlled, primary prevention trial to determine whether daily supplementation with a-tocopherol, beta-carotene, or both would reduce the incidence of lung or other cancers among male smokers. Between 1985 and 1988, 29,133 men ages 50 to 69 years, who smoked at least five cigarettes per day, were recruited from southwestern Finland. Participants were randomly assigned to receive either a-tocopherol as dl-a-tocopheryl acetate (50 mg/day), beta-carotene as all-trans-beta-carotene (20 mg/day), both supplements, or placebo capsules for 5-8 years (median 6.1 years) through April 30, 1993. Post-intervention follow-up has continued through the Finnish Cancer Registry and other national registries, and epidemiological analyses continue to be conducted.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Male smokers in Southwestern Finland
  • Stroke
  • Diabetes Mellitus
  • Heart Disease
  • Cancer
Not Provided
Healthy Volunteers
Male smokers in Southwestern Finland

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29133
25000
Not Provided
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  • INCLUSION CRITERIA:

Current smokers (five or more cigarettes per day at study entry) from Southwestern Finland.

EXCLUSION CRITERIA:

  • Females
  • Proven malignancy (except nonmelanoma skin cancer or cancer in situ)
  • Severe angina pectoris
  • Chronic renal insufficiency
  • Cirrhosis of the liver
  • Chronic alcoholism
  • Anticoagulant therapy
  • Use of supplements containing vitamin E greater than 20 mg/day, or vitaming A greater than 20,000 IU/day, or beta-carotene greater than 6 mg/day
Sexes Eligible for Study: Male
50 Years to 69 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Finland
United States
 
NCT00342992
999995012
OH95-C-N012
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
National Institute for Health and Welfare, Finland
Principal Investigator: Demetrius A Albanes, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
September 13, 2018